This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.

The primary hypotheses are as follows:

The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.

9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.

The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

Percentage of Participants With Injection Site Adverse Experiences (AEs) [ Time Frame: up to 5 days after any vaccination ] [ Designated as safety issue: Yes ]

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.

Percentage of Participants With Systemic AEs [ Time Frame: up to 15 days after any vaccination ] [ Designated as safety issue: Yes ]

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.

Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) [ Time Frame: up to 5 days after any vaccination ] [ Designated as safety issue: Yes ]

Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.

The base study V503-002 was a 12-month study that is collecting safety and immunogenicity information for six months following the subjects' third dose of study vaccine.

An optional extension study (V503-002 EXT1) will collect safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT1.

An optional second extension study (V503-002 EXT2) will collect long-term safety and immunogenicity information through approximately 10 years. No study vaccine will be administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT2.

Eligibility

Ages Eligible for Study:

9 Years to 26 Years (Child, Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Boys and Girls Age 9 to 15:

Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7

Women Age 16 to 26:

Participant has never had Pap testing or has had only normal results

Participant has had 0 to 4 sexual partners at the time of enrollment

Exclusion Criteria:

Boys and Girls Age 9 to 15:

History of allergic reaction that required medical intervention

Currently enrolled in any other clinical study

Participant is pregnant

Participant is immunocompromised or has taken immunosuppressants in the last year

Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial

Participant has a history of positive test for HPV

Women Age 16 to 26:

History of allergic reaction that required medical intervention

Currently enrolled in any other clinical study

Participant is pregnant

Participant is immunocompromised or has taken immunosuppressants in the last year

Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial

Participant has a history of positive test for HPV

Participant has a history of abnormal cervical biopsy result

Participant has a history of external genital lesions

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943722